Convival Hrono

Leaflet included in the packaging: patient information

Convival Chrono, 500 mg, prolonged-release tablets

Sodium valproate
This
medicinal
product
will
also
be
monitored.
This
will
allow
for
the
rapid
identification
of
new
safety
information.
The
user
of
the
medicine
can
also
help
by
reporting
any
undesirable
effects
that
occurred
after
using
the
medicine.
To
find
out
how
to
report
undesirable
effects,
see
section
4.

WARNING

Convival Chrono (valproate) used during pregnancy can harm the unborn child.
Women of childbearing age should use effective contraception (birth control) without interruption throughout the entire treatment period with Convival Chrono.
The treating doctor will discuss this with the patient, but the patient must also follow the recommendations presented in section 2 of this leaflet.
The patient must contact the treating doctor immediately if they plan to become pregnant or suspect they are pregnant.
Convival Chrono should not be discontinued unless advised by the doctor, as the patient's condition may worsen.
The patient must carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The patient should keep this leaflet to be able to read it again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Convival Chrono and what is it used for.
• 2. Important information before using Convival Chrono.
• 3. How to use Convival Chrono.
• 4. Possible undesirable effects.
• 5. How to store Convival Chrono.
• 6. Other information.

1. What is Convival Chrono and what is it used for

Convival Chrono is a prolonged-release tablet that contains the active substance sodium valproate, which belongs to the group of antiepileptic drugs and has an effect on the central nervous system.
The medicine has an anticonvulsant effect in various forms of epilepsy in humans.
Convival Chrono is used to treat epilepsy and mania.
Convival Chrono is used to treat:

• epilepsy, in generalized seizures:
• myoclonic seizures;
• tonic-clonic seizures;
• atonic seizures;
• absence seizures;
• epilepsy, in partial seizures:
• simple or complex partial seizures;
• secondarily generalized seizures;
• Lennox-Gastaut syndrome.
• mania, which is a condition where the patient feels very excited, elated, agitated, enthusiastic, or overactive. Mania occurs in a disease known as bipolar affective disorder. Convival Chrono may be used if lithium cannot be used.

2. Important information before using Convival Chrono

When not to use Convival Chrono

Convival Chrono should not be used:

• in case of hypersensitivity to sodium valproate or any other component of the medicine;
• in case of acute and chronic hepatitis;
• in patients with a history of severe hepatitis, especially drug-induced or in patients with a family history of severe hepatitis;
• in case of porphyria;
• in case of concomitant use with mefloquine;
• if the patient has a genetic disorder that causes mitochondrial disorders (e.g., Alpers-Huttenlocher syndrome).

Bipolar affective disorder

• In the case of bipolar affective disorder, Convival Chrono should not be used if the patient is pregnant.
• In the case of bipolar affective disorder, if the patient is of childbearing age, Convival Chrono should not be taken unless the patient uses effective contraception (birth control) throughout the entire treatment period with Convival Chrono. Convival Chrono and contraception should not be discontinued unless discussed with the doctor. The treating doctor will provide further guidance (see below "Pregnancy, breastfeeding, and fertility - Important note for women").

Epilepsy

• In the case of epilepsy, Convival Chrono should not be used if the patient is pregnant, unless no other therapy is effective.
• In the case of epilepsy, if the woman is of childbearing age, Convival Chrono should not be taken unless the patient uses effective contraception (birth control) throughout the entire treatment period with Convival Chrono. Convival Chrono and contraception should not be discontinued unless discussed with the doctor. The treating doctor will provide further guidance (see below "Pregnancy, breastfeeding, and fertility - Important note for women").

Warnings and precautions

• Before starting treatment and periodically during the first 6 months of treatment, laboratory tests of liver function should be performed.
• In case of sudden onset of the following symptoms: weakness, loss of appetite, drowsiness, recurrent vomiting, and abdominal pain, jaundice (yellowing of the skin and whites of the eyes), or recurrence of seizures, especially during the first 6 months of treatment, the doctor should be informed immediately.

In rare cases, Convival Chrono may cause severe liver damage, which can be life-threatening.

• In case of severe abdominal pain, the doctor should be informed immediately. Very rarely, Convival Chrono can cause severe pancreatitis, which can be life-threatening.
• A small number of people taking antiepileptic drugs containing sodium valproate have thought about harming themselves or committing suicide. If such thoughts occur, the doctor should be contacted immediately.
• Before starting treatment, as well as before surgery and in case of bruising or spontaneous bleeding, laboratory tests (blood morphology with smear, including platelet count, bleeding time, and coagulation tests) are recommended.
• Convival Chrono should be used with caution in patients with impaired renal function. The doctor may recommend a lower dose of the medicine.
• The medicine should be used with caution in patients with systemic lupus erythematosus.
• Convival Chrono should be used with caution in patients with metabolic disorders, especially with congenital enzyme deficiencies, such as disorders of the urea cycle, due to the possibility of increased blood ammonia levels.
• Weight gain may occur in patients treated with sodium valproate.
• Before starting Convival Chrono, the patient should discuss with their doctor if there is a family history of mitochondrial disorders.

CONTACT YOUR DOCTOR IMMEDIATELY

• Rarely, Convival Chrono may cause severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), polymorphic erythema, and angioedema. If the patient notices any symptoms associated with these severe skin reactions, they should contact their doctor immediately.

Before taking this medicine, the patient should discuss it with their doctor

• If the patient has ever had a severe skin rash or blistering of the skin after taking sodium valproate.

Children and adolescents

Convival Chrono should not be used in children and adolescents under 18 years of age for the treatment of mania.

Convival Chrono and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those obtained without a prescription.
Some medicines may affect the action of sodium valproate, and sodium valproate may affect the action of other medicines:
These include:

• neuroleptics (used to treat psychotic disorders);
• medicines used to treat depression, MAO inhibitors;
• benzodiazepines used to treat insomnia and anxiety disorders;
• other medicines used to treat epilepsy, including phenobarbital, phenytoin, primidone, lamotrigine, carbamazepine, felbamate, topiramate;
• zidovudine (used to treat HIV infection and AIDS);
• mefloquine (used to treat and prevent malaria);
• salicylates (acetylsalicylic acid);
• anticoagulants;
• cimetidine (used to treat stomach ulcers);
• erythromycin, rifampicin, carbapenem, imipenem, and meropenem (antibiotics);
• metamizole, a medicine used to treat pain and fever, may reduce the effectiveness of sodium valproate;
• clozapine (used to treat mental illnesses).

These medicines may affect the action of sodium valproate and vice versa. The patient may need to adjust the dose of individual medicines or use other medicines. The doctor will inform the patient about these changes in treatment.
The doctor will also provide additional information about medicines that should be used with caution or avoided during treatment with Convival Chrono.
The patient should avoid concomitant use of carbapenem antibiotics (used to treat bacterial infections) and sodium valproate, as this may reduce the effectiveness of sodium valproate.

Convival Chrono with food, drink, and alcohol

The medicine should be taken with meals.
Sodium valproate may enhance the effects of alcohol.

Pregnancy, breastfeeding, and fertility

The medicine should not be used during pregnancy or in women of childbearing age unless prescribed by a doctor. Women of childbearing age should use effective contraception during treatment.

Important note for women

Bipolar affective disorder

• In the case of bipolar affective disorder, Convival Chrono should not be used if the patient is pregnant.
• In the case of bipolar affective disorder, if the patient is of childbearing age, Convival Chrono should not be taken unless the patient uses effective contraception (birth control) throughout the entire treatment period with Convival Chrono. Convival Chrono and contraception should not be discontinued unless discussed with the doctor. The treating doctor will provide further guidance.

Epilepsy

• In the case of epilepsy, Convival Chrono should not be used if the patient is pregnant, unless no other therapy is effective.
• In the case of epilepsy, if the woman is of childbearing age, Convival Chrono should not be taken unless the patient uses effective contraception (birth control) throughout the entire treatment period with Convival Chrono. Convival Chrono and contraception should not be discontinued unless discussed with the doctor. The treating doctor will provide further guidance.

Risk of taking valproate during pregnancy (regardless of the disease for which valproate is used)

• The patient should consult their doctor immediately if they plan to become pregnant or are pregnant.
• Taking valproate during pregnancy carries a risk. The higher the dose, the greater the risk, but no dose is completely safe.
• Valproate may cause serious birth defects and affect the development of the child. The most common birth defects reported include spina bifida (when the spine does not develop properly); developmental abnormalities of the face and skull; developmental abnormalities of the heart, kidneys, urinary tract, and genital organs, and limb abnormalities, as well as related developmental abnormalities affecting several organs and body parts. Birth defects can cause disability, which can be significant.

Children exposed to valproate in utero have been reported to have developmental abnormalities of the eye, along with other birth defects. Developmental abnormalities of the eye can affect vision.

• Children born to mothers who took valproate during pregnancy have a higher risk of birth defects that require treatment. Valproate has been used for many years, and it is known that in a group of children born to mothers who took valproate, about 10 children out of 100 had birth defects. For comparison, such defects are found in 2-3 children out of every 100 born to women without epilepsy.
• It is estimated that up to 30-40% of children in preschool age whose mothers took valproate during pregnancy may exhibit early developmental problems. Children with this condition may start walking and talking later, be less intellectually agile than other children, have language problems, and have memory problems.
• Children exposed to valproate are more likely to be diagnosed with various autistic disorders, and some evidence suggests that these children may be more likely to develop symptoms of attention deficit/hyperactivity disorder (ADHD).
• Before prescribing this medicine, the doctor will explain to the patient what may endanger the child if the patient becomes pregnant while taking valproate. If the patient taking this medicine decides to have a child, they should not stop taking the medicine or contraception without discussing it with their doctor.
• Parents or guardians of girls treated with valproate should contact the treating doctor when their child starts menstruating.
• The patient should ask their doctor about taking folic acid when trying to conceive. Folic acid may reduce the overall risk of spina bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that taking folic acid will reduce the risk of birth defects associated with valproate treatment.

Please choose one of the following situations that applies to the patient and read the information:

• STARTING TREATMENT WITH CONVIVAL CHRONO
• CONTINUING TREATMENT WITH CONVIVAL CHRONO WITHOUT TRYING TO CONCEIVE
• CONTINUING TREATMENT WITH CONVIVAL CHRONO WHILE TRYING TO CONCEIVE
• UNPLANNED PREGNANCY WHILE CONTINUING TREATMENT WITH CONVIVAL CHRONO

STARTING TREATMENT WITH CONVIVAL CHRONO

If Convival Chrono is prescribed for the first time, the treating doctor will explain the risk to the unborn child if the patient becomes pregnant. Women of childbearing age should ensure that they use effective contraception throughout the entire treatment period with Convival Chrono. The patient should consult their doctor or family planning clinic if they need advice on contraception.

Important information:

• Before starting Convival Chrono, pregnancy should be ruled out using a pregnancy test, the results of which should be confirmed by the treating doctor.
• The patient should use effective contraception (birth control) throughout the entire treatment period with Convival Chrono.
• The patient should discuss effective contraception (birth control) with their treating doctor. The treating doctor will provide information on pregnancy prevention and may refer the patient to a specialist for advice on contraception.
• The patient should have regular check-ups (at least once a year) with a specialist in the treatment of bipolar affective disorder or epilepsy. During this visit, the treating doctor will ensure that the patient is well-informed and understands all the risks and advice related to taking valproate during pregnancy.
• The patient should inform their doctor if they plan to have a child.
• The patient should inform their doctor immediately if they are pregnant or suspect they may be pregnant.

CONTINUING TREATMENT WITH CONVIVAL CHRONO WITHOUT TRYING TO CONCEIVE

If the patient continues treatment with Convival Chrono and does not plan to become pregnant, they must ensure that they use effective contraception without interruption throughout the entire treatment period with Convival Chrono. The patient should consult their doctor or family planning clinic if they need advice on contraception.

Important information:

• The patient should use effective contraception (birth control) throughout the entire treatment period with Convival Chrono.
• The patient should discuss contraception (birth control) with their treating doctor. The treating doctor will provide information on pregnancy prevention and may refer the patient to a specialist for advice on contraception.
• The patient should have regular check-ups (at least once a year) with a specialist in the treatment of bipolar affective disorder or epilepsy. During this visit, the treating doctor will ensure that the patient is well-informed and understands all the risks and advice related to taking valproate during pregnancy.
• The patient should inform their doctor if they plan to have a child.
• The patient should inform their doctor immediately if they are pregnant or suspect they may be pregnant.

CONTINUING TREATMENT WITH CONVIVAL CHRONO WHILE TRYING TO CONCEIVE

TO CONCEIVE

If the patient plans to have a child, they should first make an appointment with their treating doctor. The patient should not stop taking Convival Chrono or contraception without discussing it with their treating doctor. The treating doctor will provide further guidance. Children born to mothers who took valproate during pregnancy are at serious risk of birth defects and developmental problems, which can significantly affect the child. The treating doctor will refer the patient to a specialist in the treatment of bipolar affective disorder or epilepsy to assess alternative treatment options. The specialist may decide to change the dose of Convival Chrono or switch to another medicine, or stop treatment with Convival Chrono long before the patient becomes pregnant - to ensure that the disease is stable. The patient should ask their doctor about taking folic acid when trying to conceive. Folic acid may reduce the overall risk of spina bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that taking folic acid will reduce the risk of birth defects associated with valproate treatment.

Important information:

• The patient should not stop taking Convival Chrono without the doctor's decision.
• The patient should not stop using contraception before discussing it with their treating doctor and developing a plan to ensure control of their condition and minimize risks to the child.
• First, the patient should make an appointment with their treating doctor. During this visit, the treating doctor will ensure that the patient is well-informed and understands all the risks and advice related to taking valproate during pregnancy.
• The treating doctor will try to switch to another medicine or stop treatment with Convival Chrono long before the patient becomes pregnant.
• The patient should schedule an urgent appointment with their treating doctor if they are pregnant or suspect they may be pregnant.

UNPLANNED PREGNANCY WHILE CONTINUING TREATMENT WITH CONVIVAL CHRONO

The patient should not stop taking Convival Chrono without discussing it with their treating doctor, as their condition may worsen. The patient should schedule an urgent appointment with their doctor if they are pregnant or suspect they may be pregnant. The treating doctor will provide further guidance. Children born to mothers who took valproate during pregnancy are at serious risk of birth defects and developmental problems, which can significantly affect the child. The patient will be referred to a specialist in the treatment of bipolar affective disorder or epilepsy to assess alternative treatment options. In exceptional circumstances, when Convival Chrono is the only available treatment option during pregnancy, the patient will be closely monitored, both in terms of disease treatment and fetal development. The patient and their partner will receive counseling and support regarding the pregnancy affected by valproate. The patient should ask their doctor about taking folic acid. Folic acid may reduce the overall risk of spina bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that taking folic acid will reduce the risk of birth defects associated with valproate treatment.

Important information:

• The patient should schedule an urgent appointment with their treating doctor if they are pregnant or suspect they may be pregnant.
• The patient should not stop taking Convival Chrono unless the doctor decides to do so.
• The patient must be referred to a specialist in the treatment of epilepsy or bipolar affective disorder to assess the need for alternative treatment options.
• The patient must receive counseling on the risk of taking Convival Chrono during pregnancy, including teratogenic effects and the impact on child development.
• The patient must be referred to a specialist for prenatal monitoring to detect possible developmental abnormalities.

The patient should read the patient guide provided by their treating doctor. The treating doctor will discuss the annual confirmation form regarding the risk and ask the patient to sign and keep it. The patient will also receive a Patient Card from the pharmacist

to remind them of the risk of taking valproate during pregnancy.

Important note for male patients

Possible risk associated with taking valproate in the 3 months before conception
A study suggests a possible risk of motor disorders and developmental delays (problems with early childhood development) in children whose fathers were treated with valproate in the 3 months before conception. In this study, such disorders occurred in about 5 out of 100 children whose fathers were treated with valproate, compared to about 3 out of 100 children whose fathers were treated with lamotrigine or levetiracetam (other medicines that may be used to treat the patient's condition). The risk to children whose fathers stopped taking valproate at least 3 months before conception is unknown. The study has limitations, and therefore, it is not clear whether the suggested increased risk of developmental disorders is caused by valproate. The study was not large enough to show what specific types of developmental disorders are associated with this risk.

• The doctor will discuss with the patient the possible risk to children whose fathers were treated with valproate;
• The need to consider using effective contraception (birth control) by the patient and their partner during treatment and for 3 months after its completion;
• The need to consult a doctor when planning to conceive and before stopping contraception;
• The possibility of using other treatment methods for the disease, depending on the individual situation.

The patient should not donate sperm while taking valproate and for 3 months after stopping it. If the patient plans to have a child, they should discuss it with their doctor. If the patient's partner becomes pregnant while the patient is taking valproate in the 3 months before conception and the patient has questions related to this, they should contact their doctor. The patient should not stop taking the medicine without consulting their doctor. If the patient stops taking the medicine, their symptoms may worsen. The patient should regularly visit their prescribing doctor. During such a visit, the doctor will discuss with the patient the precautions related to taking valproate and the possibility of using other treatment methods for their disease, depending on their individual situation. The patient should read the patient guide provided by their treating doctor. The patient will also receive a Patient Card from the pharmacist to remind them of the possible risk associated with taking valproate.

Breastfeeding

The medicine passes into breast milk to a small extent. No undesirable effects have been observed in breastfed children; however, the patient should consult their doctor before breastfeeding while taking Convival Chrono.

Driving and using machines

In some patients, during treatment with Convival Chrono, drowsiness may occur, especially when using several antiepileptic medicines or when concomitantly using benzodiazepines. Before driving or operating machinery, the patient should make sure how they react to the treatment.

Convival Chrono contains sodium

This medicine contains 70 mg of sodium (the main component of table salt) per tablet. This corresponds to 3.5% of the recommended maximum daily intake of sodium in the diet for adults.

3. How to use Convival Chrono

Girls and women of childbearing age

Treatment with Convival Chrono should be started and supervised by a doctor specializing in the treatment of epilepsy or bipolar affective disorder.

Male patients

It is recommended that the use of Convulex be started and supervised by a specialist in the treatment of epilepsy or bipolar affective disorder - see section 2 Important note for male patients.
Convival Chrono should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The use of the prolonged-release formulation allows Convival Chrono to be taken in a single daily dose or in two divided doses per day.
If indicated, Convival Chrono prolonged-release tablets may be used in children with a body weight above 17 kg, provided that the tablet can be swallowed.
This formulation is not suitable for children under 6 years of age (risk of choking).
The daily dose of Convival Chrono should be determined based on the patient's age and body weight, and the doctor should always consider the patient's individual sensitivity to valproate.
Changing therapy to prolonged-release formulations
In the case of switching from conventional tablets to prolonged-release tablets, it is recommended (according to current knowledge) to maintain the same daily dose.
Starting treatment with Convival Chrono
In the case of starting treatment with Convival Chrono as the only antiepileptic medicine, the dose should be increased every 2-3 days to reach the average recommended dose in one week.
In the case of introducing Convival Chrono in patients already treated with other antiepileptic medicines, the dose of Convival Chrono should be gradually increased to the average recommended dose over a period of 2 weeks. Subsequently, the dose of other medicines should be reduced to the extent that ensures optimal control of seizures or discontinued if possible.
In the case of adding other antiepileptic medicines to the treatment, they should be introduced gradually.
The initial daily dose is usually 5 to 15 mg/kg body weight and should be increased gradually every 2-3 days by 5 mg/kg body weight until the optimal dose is reached (see: Starting treatment with Convival Chrono).
Usually, the daily dose is 20 to 30 mg/kg body weight, given in a single dose or in two divided doses.
If necessary, the daily dose may be higher than 50 mg/kg body weight, provided that close clinical monitoring of the patient's condition is maintained (see: When to exercise special caution when using Convival Chrono).
Children over 17 kg body weight
The target dose is 30 mg/kg body weight per day.
Adults
The target dose is 20 to 30 mg/kg body weight per day.
Elderly patients
Dosing should be based on the control of seizures.
Patients with impaired renal function
The doctor may decide to modify the dose in the patient.

Mania

The daily dose should be determined and checked individually by the treating doctor.
Initial dose:
The recommended initial daily dose is 750 mg.
Average daily dose:
The average daily dose is usually between 1000 mg and 2000 mg.

Duration of treatment

The medicine should be used for as long as the doctor recommends.
If the patient feels that the effect of Convival Chrono is too strong or too weak, they should consult their doctor.

Taking a higher dose of Convival Chrono than recommended

Symptoms of severe valproate overdose include: drowsiness, decreased muscle tone and reflexes, pinpoint pupils, respiratory depression; metabolic acidosis may also occur. Other symptoms may also occur, including seizures in case of increased intracranial pressure with brain edema.
In case of taking a higher dose of Convival Chrono than recommended, the patient should contact their doctor or pharmacist immediately.
Hospital treatment in case of poisoning should include: gastric lavage (up to 10-12 hours after taking the medicine), constant monitoring of cardiovascular and respiratory function. In severe cases, hemodialysis or even exchange transfusion may be necessary.

Missing a dose of Convival Chrono

In case of missing a dose, the patient should take it as soon as possible, unless it is close to the time for the next dose.
The patient should not take a double dose to make up for the missed dose. The patient should not take two doses of the medicine in a short period.
In case of doubts, the patient should consult their doctor.

Stopping treatment with Convival Chrono

The patient should not stop taking Convival Chrono without consulting their doctor.
The patient should not change the dose of Convival Chrono without consulting their doctor.
In such cases, the patient's condition may worsen.
In case of any further doubts related to the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, Convival Chrono can cause undesirable effects, although not everybody gets them.
If any of the undesirable effects worsen or any undesirable effects not listed in the leaflet occur, the patient should tell their doctor or pharmacist.
Rarely, undesirable effects can be serious. Patients may need appropriate treatment in case of certain undesirable effects.
The following may occur:

• gastrointestinal disorders: nausea, abdominal pain, diarrhea, especially at the beginning of treatment; very rarely, pancreatitis, sometimes life-threatening;
• -nervous system disorders: sedation, extrapyramidal disorders; disorientation; in individual cases, a state of stupor or lethargy, sometimes leading to transient coma; very rarely, transient confusion, isolated transient symptoms of parkinsonism (muscle stiffness, tremors);
• confusion (disorientation);
• rare cases of liver damage;
• isolated and moderate increases in blood ammonia levels without changes in liver function tests;
• hyponatremia (decreased sodium levels in the blood), syndrome of inappropriate antidiuretic hormone secretion;
• obesity (rarely)
• blood and lymphatic system disorders: often, thrombocytopenia (decreased platelet count in peripheral blood) may occur, rarely, anemia, leukopenia (decreased white blood cell count in peripheral blood), or pancytopenia (decreased red, white, and platelet blood cell count in peripheral blood), bone marrow failure, including aplastic anemia;
• vasculitis;
• -skin and subcutaneous tissue disorders: nail and nail bed disorders (often); skin reactions, such as rash, and often, transient and (or) dose-dependent hair loss;
• menstrual disorders in women;
• hearing impairment, both transient and non-transient;
• moderate limb edema;
• angioedema, severe hypersensitivity reaction including drug rash with eosinophilia and systemic symptoms (DRESS), polymorphic erythema.
• weight gain;
• renal disorders and very rarely, involuntary urination;
• double vision (rarely);
• darkening of skin and mucous membranes (hyperpigmentation)

The patient should contact their doctor immediately if they experience any of the following serious undesirable effects, as they may require urgent medical attention:

• changes in behavior related or unrelated to an increased frequency of seizures or their severity, especially when concomitantly using phenobarbital or during rapid dose escalation of Convival Chrono;
• weakness, loss of appetite, drowsiness, recurrent vomiting, and abdominal pain, jaundice (yellowing of the skin and whites of the eyes), or recurrence of seizures - these symptoms may indicate liver damage;
• coagulation disorders, spontaneous bruising, and bleeding;
• skin and mucous membrane changes - very rarely, severe skin reactions may occur: toxic epidermal necrolysis, Stevens-Johnson syndrome, polymorphic erythema.
• difficulty breathing, chest pain or feeling of pressure in the chest (especially when inhaling), shortness of breath, and dry cough due to fluid accumulation around the lungs (pulmonary effusion)

There are reports of bone disorders associated with osteopenia, osteoporosis (bone "thinning"), and fractures. The patient should consult their doctor or pharmacist if they are taking long-term antiepileptic therapy, have osteoporosis, or are taking steroids.

Additional undesirable effects in children

Certain undesirable effects of valproate occur more frequently or have a more severe course in children than in adults. These include liver damage, pancreatitis, aggression, agitation, attention disorders, abnormal behavior, hyperactivity, and learning disorders.

5. How to store Convival Chrono

No special precautions are required for the storage temperature of the medicinal product. The container should be tightly closed after each use. Store in a place out of sight and reach of children. Do not use Convival Chrono after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the given month. The batch number is stated on the packaging after Lot. Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Other information

What Convival Chrono contains

The active substance of the medicinal product is sodium valproate (Natrii valproas). Each prolonged-release tablet contains 500 mg of sodium valproate. Excipients: Tablet core: Citric acid monohydrate, Ethylcellulose, Methacrylic acid copolymer (type B), Talc, Silica colloidal anhydrous, Magnesium stearate, Coating: Methacrylic acid copolymer (type A), Methacrylic acid copolymer (type B), Talc, Sodium carmellose, Titanium dioxide (E 171), Triethyl citrate, Vanillin, contains sorbic acid

What Convival Chrono looks like and what the pack contains

White oval prolonged-release tablets with a score line and engraved with CC5 on one side. The tablet can be divided into two equal parts. Pack sizes: 50 tablets, 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH, Schlossplatz 1, A-8502 Lannach, Austria

To obtain more detailed information about this medicinal product, please contact the representative of the marketing authorization holder

G.L. PHARMA POLAND Sp. z o.o., Al. Jana Pawła II 61/313, 01-031 Warsaw, Poland, Tel: 022/ 636 52 23; 636 53 02, biuro@gl-pharma.pl

Date of last update of the leaflet: